Assay Device Quantitative Detection via Zone Segmentation
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Solution Overview
Problem
Current lateral flow immunoassays are non-quantitative and lack sensitivity, making it difficult to achieve rapid and accurate test results in fields like food and medical diagnostics.
Innovation Solution
The development of an assay device with a receptacle, plunger, and membrane that includes a target conjugate zone, wick, and detection zone, where affinity components and capture compounds are used to immobilize and detect target analytes, generating a detectable signal through reactions with reagents, allowing for quantitative analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional lateral flow immunoassay is used, then the test is simple and rapid, but the results are non-quantitative and lack sensitivity
Solution Approach 1:
The assay device is divided into distinct functional zones: a sample application zone, a detection zone with capture compounds, and a readout zone. This segmentation allows each zone to perform its specific function optimally while maintaining overall device simplicity for quantitative measurement
Solution Approach 2:
Capture compounds are introduced as an intermediary element in the detection zone to bind target analytes, enabling quantitative measurement through controlled interactions rather than direct detection, thus improving measurement precision without significantly increasing device complexity
2Reliability
If traditional lateral flow immunoassay is used, then the device is simple to operate, but sensitivity is insufficient for accurate detection
Solution Approach 1:
The membrane is treated with different properties in different regions: the detection zone contains immobilized capture compounds with high affinity for target analytes, while other zones maintain standard lateral flow properties. This local differentiation enhances detection sensitivity without complicating overall device operation
Solution Approach 2:
Capture compounds are pre-immobilized in the detection zone during manufacturing, preparing the device in advance for sensitive target analyte detection. This preliminary preparation ensures high sensitivity upon use while maintaining ease of operation as no additional preparation steps are required
3Measurement precision
If quantitative detection is implemented, then accurate test results are achieved, but background signals increase interference
Solution Approach 1:
The detection is spatially separated into distinct zones: target analyte binding occurs in the detection zone with capture compounds, while signal generation and detection occur in a separate readout zone. This extraction of detection functions reduces background signal interference and improves quantitative accuracy
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables simple, rapid, and quantitative detection of target analytes, providing reliable results in diagnostic applications by minimizing background signals and optimizing the flow path for accurate analyte detection.
Implementation Method 1
a wick providing capillary force
Implementation Method 2
a target conjugate zone in which a plurality of affinity components are disposed; a plurality of capture compounds are immobilized in a detection zone
Implementation Method 3
quantitative test results, such as using chemiluminescence, fluorescence, colorimetry, etc.
Implementation Method 4
quantitative test results, such as using chemiluminescence, fluorescence, colorimetry, etc.
Data Source
AI summary
Assay devices are provided including a receptacle having a sample entry port; a plunger disposed within the receptacle; at least one reagent; a membrane attached to a first surface of the plunger; a wick providing capillary force; and a detection zone. The membrane includes a target conjugate zone in which affinity components are disposed. Capture compounds are immobilized in a detection zone, which is located between the target conjugate zone and the wick. A method of detecting a target analyte is also provided, including providing the assay device; providing a sample suspected to contain a target analyte; adding the sample onto the device; allowing the sample to travel along the membrane until the sample reaches the detection zone; immobilizing the target analyte through reaction of the target analyte with the capture compounds; reacting the immobilized target analyte with a reagent to generate a detectable signal; and detecting the generated signal.